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MEDTRONIC HEART VALVES DIVISION EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number D-EVOLUTFX-2329 |
| Device Problems
Difficult or Delayed Positioning (1157); Perivalvular Leak (1457); Inaccurate Delivery (2339); Difficult or Delayed Activation (2577); Malposition of Device (2616); Difficult to Open or Close (2921); Device Dislodged or Dislocated (2923)
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| Patient Problems
Cardiovascular Insufficiency (4445); Valvular Insufficiency/ Regurgitation (4449)
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| Event Date 11/08/2022 |
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Event Type
Injury
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Event Description
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Medtronic received information that immediately following deployment of this transcatheter bioprosthetic valve (f157691) at a depth of 3 mm, the valve dislodged out of the annulus into the ascending aorta as the delivery catheter system (dcs) (0011319442) was withdrawn from the ventricle.The valve was snagged by the tip of the nosecone on the dcs, dislodging the valve out of the annulus.A second transcatheter valve (d740195) was attempted to be deployed, however was recaptured twice due to an implant depth that was too deep.During the second recapture, the physician stated that the gray and blue handles of the dcs (0011404213) were completely together, however the valve was not fully enclosed in the capsule and was protruding from the end out of the catheter sheath.The physician overdrove the dcs several turns in order for the capsule to fully cover the valve and connect flush with the nosecone on the dcs.During the third deployment, the physician stopped turning the deployment knob at 80%, with a photon of light still present before the radio-plaque marker.The physician stepped off fluoroscopy.The physician then cinied an aortogram while injecting contrast.It was reported that the valve paddles were no longer within the paddle pockets; the valve had self-deployed.The valve was far deep into the ventricle, at a depth of 7 to 10 mm on the non-coronary cusp (ncc).As a result, severe paravalvular leak (pvl) was present.Hemodynamic instability was reported.The procedure was converted to an open surgical procedure.Both transcatheter valves were explanted.A surgical aortic valve was implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: evolutfx-29, serial/lot #: (b)(4), ubd: 09-aug-2024, udi#: (b)(4); product id: evolutfx-29, serial/lot #: (b)(4), ubd: 03-dec-2023, udi#: (b)(4); product id: d-evolutfx-2329, serial/lot #: (b)(4), ubd: 14-sep-2023, udi#: (b)(4) product analysis: no products were returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received that when the first delivery catheter system (dcs) was being withdrawn from the ventricle, it interacted with the first valve causing it to dislodge.The second valve was deployed "far deep" at a depth of 15 millimeter (mm).The patient was reported to be "doing well" post surgical valve placement.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at medtronic¿s quality laboratory, the second delivery catheter system (dcs) (0011404213) handle appeared intact.The device was received with the capsule fully closed.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.The inner member shaft and spindle hub appeared intact with no evidence of damage.There was a bend to the outer member.An evolut fx 26mm valve (d537858) was successfully loaded onto the dcs without issue.On retraction of the capsule via the rotation of the deployment knob, the valve deployed without issue and with the valve paddles still in the pockets on the spindle attachment.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Conclusion: procedural images were provided for review.The first image showed the second transcatheter valve just prior to the paddles fully releasing.The image provided shows the delivery catheter system to be beyond the point of recapture.At this stage the valve can release without trying to deploy due to the beating of the heart and the paddles not being fully secure in the pocket.This would be at a point to deploy with intent.Second image shows the valve released in a deep position.Without additional imaging showing the photon of light like stated above the valve appears to have released itself due to being beyond the point of recapture.The second dcs used during the procedure was returned to medtronic for analysis.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.Delamination typically occurs when the capsule is subjected to a bending force.There was a bend to the outer member.It is possible that this bend occurred during preparation of the device to return for analysis.An evolut fx 26mm valve was successfully loaded onto the dcs without issue.On retraction of the capsule via the rotation of the deployment knob, the valve deployed without issue and with the valve paddles still in the pockets on the spindle attachment.There was no other damage noted to the remainder of the device.The device history records for the second dcs and the second valve were reviewed and showed that these products met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Dislodgement of the valve by the distal tip is related to operator technique or experience.The device instructions for use (ifu), instructs ¿under fluoroscopic guidance, confirm that the catheter tip is coaxial with the inflow portion of the bioprosthesis¿ prior to drawing the dcs tip through the valve.No images capturing the reported dislodgement were received for review.Given the limited information, the root cause of the dislodgement event cannot be confirmed.Events of this type do not indicate a device malfunction or a failure to meet manufacturing specifications.Recapturing is a feature of the device that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.There is no information to suggest a device quality deficiency that may have caused or contributed to this event, but the cause of the positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.The force in the dcs when closing the capsule is cumulative and many sources may contribute to the feeling of excess tension including load quality, bends and kinks on the shaft, and tortuous anatomy.Based on the limited information available, the cause of the difficulty recapturing cannot be determined.It seems most likely that the physician had reached the point of no recapture resulting in the valve paddles no longer being within the paddle pockets and the valve self-deploying and subsequently being positioned ¿far deep¿ on deployment.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.Based on the information provided, the pvl can be attributed to the deep positioning of the valve.Hemodynamic instability can be the result of effects such as low cardiac output and hypotension, which are known potential adverse events per the device ifu.With the information available the hemodynamic instability can be attributed to the pvl and positioning of the valve upon deployment.There is no information to suggest a device malfunction or a failure to meet specifications that may have caused or contributed to this event, but a conclusive root cause cannot be determined at this time.Updated: medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Updated data: h6 - method and results code product analysis: on further analysis of the inside of the capsule using a borescope, there were two instances visible of lifting to the capsule inner material.A tear to the capsule inner material was also visible, exposing the nitinol frame.Conclusion: based on the review of the cine images provided and the review of the inside of the capsule using a borescope it seems most likely that the recapturing issues and uncontrolled deployment was due to a misload of the implant, specifically relating to the loading of the paddles into the spindle paddle pocket.As one of these paddles was not correctly loaded on to the spindle, this would have contributed to the issues encountered, however, this cannot be conclusively confirmed.There is no information to suggest a device malfunction or a failure to meet specifications that may have caused or contributed to this event, but a conclusive root cause cannot be determined at this time.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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